Taxotere Prostate Cancer New Indication Registration Trial in China

NCT00436839 | Completed Phase 3

• 1 other identifier: DOCET_L_01833
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

To compare overall survival after receiving mitoxantrone and prednisone or docetaxel and prednisone in subjects with hormone-refractory metastatic prostate cancer.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (7)

• Efficacy: Overall survival

  From beginning to end of the study

• Objective response rate of patients with measurable disease by Response Evaluation Criteria in Solid tumours

  From beginning to end of study

• Prostatic Specific Antigen response

  From the beginning to the end of study

• Pain response (McGill-Melzack Scale)

  From beginning to end of study

• Time to progression

  From beginning to end of study

• Adverse event

  From beginning to end of study

• Quality Of Life: Functional assessment of chronic illness therapy-prostate questionnaire will be used

  From beginning to end of study

Study Arms (2)

1

EXPERIMENTAL

Docetaxel 75mg/m² intravenously (day 1) every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle

Drug: Docetaxel; Drug: Prednisone

2

ACTIVE COMPARATOR

Mitoxantrone 12mg/m² intravenously every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle

Drug: Mitoxantrone; Drug: Prednisone

Interventions

Docetaxel DRUG

75mg/m² intravenously (day 1) every 21 days

1

Mitoxantrone DRUG

12mg/m² intravenously every 21 days

2

Prednisone DRUG

10mg orally given daily

1; 2

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven prostate adenocarcinoma
• Androgen independent prostate Cancer S/P orchiectomy and/or LHRH agonist Testosterone \< 50 ng/dl (ie 1.735 nmol/l)
• Documented progressive disease
• Patients should have achieved stable analgesia for 7 days
• Karnofsky Performance Status ≥ 70
• No prior treatment with cytotoxic agent (except estramustine)
• Normal cardiac function must be confirmed by Left ventricular ejection fraction
• Adequate organ function:
• Hematology:
• Neutrophils \> 1.5 x 10\^9/L
• Hemoglobin \> 10 g/dl. Erythropoietin use is allowed, but red blood cell transfusion to upgrade the hemoglobin level is not allowed
• Platelets \> 100 x 10\^9/L
• Hepatic function:
• Total bilirubin \< the upper-normal limit of the institution.
• Alanine aminotransferase and Aspartate transaminase \< 1.5 times the upper-normal limit of the institution.

You may not qualify if:

• Prior radiotherapy to \>25% of bone marrow (whole pelvic irradiation is not allowed)
• prior cytotoxic chemotherapy, except monotherapy with estramustine
• prior isotope therapy
• history of another cancer within the preceding five year
• symptomatic peripheral neuropathy grade ≥ 2
• other serious illness or medical condition:
• Congestive heart failure even if controlled. Previous history of myocardial infarction or angina pectoris within 1 year from study entry, uncontrolled hypertension or uncontrolled arrhythmias.
• Active uncontrolled infection
• Peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids.
• Auto-immune disease (lupus, sclerodermia, rheumatoid polyarthritis)
• treatment with any other anti-cancer therapy
• treatment with bisphosphonates
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Shanghai, China

Location

Related Publications (1)

• Zhou T, Zeng SX, Ye DW, Wei Q, Zhang X, Huang YR, Ye ZQ, Yang Y, Zhang W, Tian Y, Zhou FJ, Jie J, Chen SP, Sun Y, Xie LP, Yao X, Na YQ, Sun YH. A multicenter, randomized clinical trial comparing the three-weekly docetaxel regimen plus prednisone versus mitoxantone plus prednisone for Chinese patients with metastatic castration refractory prostate cancer. PLoS One. 2015 Jan 27;10(1):e0117002. doi: 10.1371/journal.pone.0117002. eCollection 2015.

  PMID: 25625938 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Mitoxantrone; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Quinones; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Jing Fu

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2007
• First Posted: February 19, 2007
• Study Start: January 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 9, 2012

Record last verified: 2012-07

Locations

CN (1)